(NewsNation Now) — Pfizer and BioNTech announced they’re applying for full approval from the U.S. Food and Drug Administration for its two-dose COVID-19 vaccine.
The vaccine has been available in the U.S. since December 11, but that is under a different waiver known as an Emergency Use Authorization. In those cases, the FDA determines the benefits of allowing a drug or medicine outweigh the risks. In clinical trials, the vaccine was 95% effective at preventing severe disease.
A full approval would signal the FDA’s full confidence in the vaccine, and would be granted based on more data.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Pfizer Chairman and Chief Executive Officer Albert Bourla, said in a news release.
The companies say they’ve administered more than 170 million doses in the U.S. since December. It’s currently available to Americans over the age of 16, assuming they have not tested positive for COVID-19 in the last 14 days and don’t have a history of extreme reactions to vaccines.
Pfizer and BioNTech are expected to get word on their request to give the shots to children as young as 12 years old next week.
This is a developing story and will be updated.